3.0.0 3710 2023-01-15T09:32:51Z 2023-01-15T09:32:51Z House H HR 2004-01-20 108 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2004-02-03T13:53:00Z Referred to 2004-01-20T17:02:15Z 2004-02-03 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2004-01-20 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2004-01-20 Introduced in House IntroReferral Intro-H 9 Library of Congress 2004-01-20 Introduced in House IntroReferral 1000 9 Library of Congress W000314 Rep. Wexler, Robert [D-FL-19] ROBERT WEXLER D FL 19 N Health Administrative procedure Administrative remedies Business records Canada Commerce Consumer protection Department of Health and Human Services Drug approvals Drug industry Drugs Foreign Trade and International Finance Government Operations and Politics Government paperwork Governmental investigations Identification devices Import restrictions Imports Intellectual property Labeling Law Medical laboratories Pharmacies Pharmacists Prescription pricing Product counterfeiting Product safety Wholesale trade Health 00 2004-01-20 Introduced in House 2004-03-17T17:33:42Z Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States. Sets forth specified provisions respecting: (1) importer and foreign seller recordkeeping and information requirements; (2) qualified laboratory drug testing; (3) registration with the Secretary of Canadian sellers; and (4) approved labeling.

Declares that the Secretary should: (1) focus enforcement on cases in which individual importation poses a significant public health threat; and (2) exercise discretion to permit individuals to make such importation for non-risk personal use.

Authorizes the Secretary to grant individuals a waiver of the prohibition of importation of a prescription drug or device. Directs the Secretary to grant individuals a waiver of such prohibition for an approved prescription drug imported from Canada that is: (1) imported from a licensed pharmacy for not more than 90-day personal use; (2) accompanied by a valid prescription; (3) in a final finished dosage that was manufactured in a registered establishment; and (4) imported under such other conditions as the Secretary determines necessary to ensure public safety.

]]> To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs. Display Title To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs. Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs. Introduced in House IH Introduced in House 2004-01-20T05:00:00Z 2004-02-03 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.